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dS Base 1.5T

Philips Neuro Coil

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838098527
Basic UDI-DI: 0884838BM411SK
Reference: 459801730051
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

dS Knee 16CH 3.0T

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838098503
Basic UDI-DI: 0884838BM412SM
Reference: 459801730031
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

dS FootAnkle Coil 8ch 1.5T

dS Small Extremity 16Ch 1.5T

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838098367
Basic UDI-DI: 0884838BM409SY
Reference: 459801729351
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

dS Breast Coil 7ch 1.5T

Philips Breast Coil

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838098121
Basic UDI-DI: 0884838BM410SH
Reference: 459801728811
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

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dS TorsoCardiac 1.5T

MR coils (dS TorsoCardiac 1.5T/dS MSK S 1.5T/dS MSK M 1.5T)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000003923
UDI-DI: 00884838096813
Basic UDI-DI: 0884838BM1162M4
Reference: 459801681991
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

DynaCAD

DynaCAD 5

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Philips DS North America LLC
Manufacturer SRN: US-MF-000035802
UDI-DI: 00884838094857
Basic UDI-DI: 0884838BM426SY
Reference: 300010314352
EMDN: Z11050182
EMDN description: MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

MR-RT CouchTop

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Philips Oy
Manufacturer SRN: FI-MF-000001621
UDI-DI: 00884838068490
Basic UDI-DI: 0884838BM289TE
Reference: 459800573514
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:10

Manufacturer products View details

Prodiva 1.5T CS

Prodiva 1.5T

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000003923
UDI-DI: 00884838064799
Basic UDI-DI: 0884838BM288TC
Reference: 781069
EMDN: Z11050103
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY GREATER THAN 0.5T
First on market country: France
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:10

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00860000606134

810-11049-01

Class IMDR 2017/745On the market

Manufacturer: Hyperfine, Inc.
Manufacturer SRN: US-MF-000029806
UDI-DI: 00860000606134
Basic UDI-DI: 0860000606100003R7
Reference: 810-11049-01
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Swoop® Portable MR Imaging® System

850-11001-06 (900-11001-06, in crate)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Hyperfine, Inc.
Manufacturer SRN: US-MF-000029806
UDI-DI: 00850043319009
Basic UDI-DI: 0860000606100001R3
Reference: 900-11001-06
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:48

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PNEUMO NONMETALIC 10' LATEX FREE

Latex-Free Non- Metallic Pneumograph

Class IMDR 2017/745On the market

Manufacturer: Lafayette Instrument Company
Manufacturer SRN: US-MF-000041816
UDI-DI: 00855170007140
Basic UDI-DI: 0855170007NMPNEUMOGRAPHU9
Reference: 76513NM10A
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Germany
Authorised representative: AJW Technology Consulting GmbH
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

3.0T 16ch Shoulder Coil

16ch Shoulder Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003909
Basic UDI-DI: 0850028932377Q
Reference: NC143202
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

3.0T 16ch Breast Coil

16ch Breast Coil

Class IMDR 2017/745On the marketActive device

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003824
Basic UDI-DI: 0850028932387S
Reference: M7006PA
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

1.5T Receive-Only 16ch Flex SPEEDER Large

16ch Flex SPEEDER Coils

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003169
Basic UDI-DI: 0850028932397U
Reference: NC043200
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

GEM Flex Interface 16ch Fixed, 1.5T P-Connector

GEM Flex Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003060
Basic UDI-DI: 0850028932407D
Reference: NC022204
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

1.5T HD 8Ch Shoulder Coil

8Ch Shoulder Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00856181003046
Basic UDI-DI: 0850028932417F
Reference: NC008901
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

3.0T AIR Open Head Neck Posterior 9ch

32Ch AIR Open Coil

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00850028932254
Basic UDI-DI: 0850028932437K
Reference: NC139200
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

Extremities Stabilizer Kit, Flex Coils

Flex Coil Accessories

Class IMDR 2017/745On the market

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00850028932131
Basic UDI-DI: 0850028932357L
Reference: NC074004
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

Guardian G1 Wireless Audio System

Wireless Audio System

Class IMDR 2017/745On the marketActive device

Manufacturer: NeoCoil, LLC
Manufacturer SRN: US-MF-000027128
UDI-DI: 00850028932155
Basic UDI-DI: 0850028932347J
Reference: NC070000
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

Siemens 3.0T Endo Interface II with Tim 4G Slide Connect (e2CoilTM)

4000518

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DxTx Medical, Inc.
Manufacturer SRN: US-MF-000026795
UDI-DI: 00850011472255
Basic UDI-DI: 08500114724000518RE
Reference: 4000518
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: MedR-AR Services B.V.
Last updated: 16.07.2026 06:10

Manufacturer products Authorised representative products Authorised representative actors View details